510(k) · Cleared
ClearedMentor Tono-Pen 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mentor Ophthalmics, Inc. · HKY Tonometer, Manual
Cleared on Nov 26, 1996 after a 28-day review. The FDA summary names its predicate without a number. 10 later devices descend from it.
- Decided
- Nov 26, 1996
- Review
- 28 days
- Class
- Class II
- Product code
- HKY
- Recalls
- None
- Predicates
- 0
10 later devices descend from it, 1 citing it directly.
- This deviceK964312 Mentor Tono-Pen 3Mentor Ophthalmics, Inc. · 1996
- Descendant · cites it directly · 9 of its ownK053430 Tono-Pen Avia Tonometer and Ocu-Shiled Tip CoverMedtronic Xomed, Inc. · 2006
- Descendant · 2 generations on · 8 of its ownK063873 Icare Tonometer TA01ITiolat OY · 2007
- Descendant · 3 generations on · 4 of its ownK153694 Icare ic100Icare Finland OY · 2016
- Descendant · 4 generations on · 2 of its ownK190316 Icare ic200Icare Finland OY · 2020
- Descendant · 3 generations on · 2 of its ownK163343 Icare HOME tonometerIcare Finland OY · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053430Tono-Pen Avia Tonometer and Ocu-Shiled Tip CoverMedtronic Xomed, Inc. · 2006 · cites it directly9descendants
- K063873Icare Tonometer TA01ITiolat OY · 2007 · 2 generations on8descendants
- K153694Icare ic100Icare Finland OY · 2016 · 3 generations on4descendants
- K190316Icare ic200Icare Finland OY · 2020 · 4 generations on2descendants
- K163343Icare HOME tonometerIcare Finland OY · 2017 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964312 | Mentor Tono-Pen 3 | Mentor Ophthalmics, Inc. | 1996 | — |
| +1 | K053430 | Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover | Medtronic Xomed, Inc. | 2006 | — |
| +2 | K063873 | Icare Tonometer TA01I | Tiolat OY | 2007 | — |
| +3 | K153694 | Icare ic100 | Icare Finland OY | 2016 | — |
| +4 | K190316 | Icare ic200 | Icare Finland OY | 2020 | — |
| +3 | K163343 | Icare HOME tonometer | Icare Finland OY | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HKY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HKY device
- #1 K241447 iCare ST500 (TA04)score 9.6 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Mentor Tono-Pen XL Named without a submission number |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053430 | Tono-Pen Avia Tonometer and Ocu-Shiled Tip Cover | 2006 | 9 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K053430 (Medtronic Xomed, Inc., 2006) has gone furthest, with 9 descendants of its own.
How does its category compare?
All HKY devicesHKY Tonometer, Manual: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · HKY
3in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · HKY
128in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HKY
2in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HKY
1in 2019
MAUDE reports naming product code HKY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 3 | 123 | 2 | 3 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 3 | 226 | 0 | 2 |
| 2017 | 2 | — | 0 | 0 |
| 2018 | 3 | 77 | 0 | 0 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 1 | — | 0 | 0 |
| 2022 | 2 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 3 | 128 | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The MENTOR TONO-PEN 3 is used to measure the intraocular pressure (IOP) during routine eye examination or when an increased IOP is suspected.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964312 · printed Nov 5, 2026
Cite this page
510(k) Report. “K964312: Mentor Tono-Pen 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K964312
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026